Summary of Clinical Use

Approved to treat chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab, or which is previously untreated. May also be beneficial in the treatment of follicular non-Hodgkin's lymphoma, diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. The effectiveness of ofatumumab against additional hematological malignancies is being investigated in Phase 3 clinical trial. In January 2015, the FDA expanded approval to include extended treatment for CLL patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive disease. In August 2016, the FDA expanded approval again to include use of ofatumumab in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The FDA approved a formulation of ofatumumab that is suitable for subcutaneous injection using an autoinjector pen (Kesimpta®, formerly OMB157) in August 2020. Kesimpta® is indicated for patients with relapsing forms of multiple sclerosis. This new formulation represents the first at home, self-administered once monthly B-cell therapy. In March 2021 the EMA issued approval for Kesimpta® to be used as a treatment for relapsing-remitting multiple sclerosis.

Mechanism Of Action and Pharmacodynamic Effects

Anti-CD20 monoclonal antibody inhibiting early stage B lymphocyte activation. Binds to a different CD20 epitope than rituximab and most other anti-CD20 antibodies.

External links

For extended ADME data see the following: Electronic Medicines Compendium (eMC) Drugs.com European Medicines Agency (EMA)